EUCTR2016-001491-29-FR进行中（未招募）1 期
A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for high-risk stage III colon cancer in adjuvant setting - IROCAS
ICANCER0 个研究点目标入组 640 人开始时间: 2016年11月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient =18 years and < 71years
- •2.Patient with ECOG =1
- •3.Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.
- •4.Curative R0 surgical resection within 42 days before randomization.
- •5.Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent
- •6.Start of study drug treatment has to be performed less than 56 days after surgery.
- •7.No prior chemotherapy.
- •8.No prior abdominal or pelvic irradiation.
- •9.Patient with adequate organ function:
- •?Absolute neutrophil count (ANC) =1.5 x 109/L
- •?Haemoglobin =9 g/dL
- •?Platelets (PTL) =100 x 109/L
- •?AST/ALT =2.5 x ULN
- •?Alkaline phosphatase =2.5 x ULN
- •?Total Bilirubin =1.5 x ULN (Upper Limit of Normal)
- •?Creatinine clearance =50 mL/min (Cockcroft and Gault formula)
- •?Carcinoembryogenic antigen (CEA) =10ng/mL after surgery (during screening period)
- •10.Adequate contraception if applicable.
- •11.Patient able and willing to comply with study procedures as per protocol
- •12.Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
- •13.Public or private health insurance coverage
- •14.Life expectancy of > or = at 5 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
- •2. Metastatic disease
- •3.Presence of inflammatory bowel disease
- •4.Known hypersensitivity reaction to any of the components of study treatments.
- •5.Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period
- •6.Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •7.Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •8.Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- •9.History or current evidence on physical examination of central nervous system disease or peripheral neuropathy = grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
- •10.Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.
- •11.Known DPD deficiency or UGTA1A1 homozygous 7/7
- •12.Patients already included in another therapeutic trial involving an experimental drug
研究者
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